EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2009 (No. 2)
Sodium citrate and sodium acid citrate
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2009 (No. 2) (the Listing Notice) is a Notice made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).
The Listing Notice has the effect of permitting the use of sodium citrate and sodium acid citrate as active ingredients in Listed medicines for oral use.
The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included in the Australian Register of Therapeutic Goods (the ARTG) before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act). Medicines are registered or listed in the ARTG, depending on the ingredients they contain and the therapeutic claims that are being made.
In general, products that contain low risk ingredients are referred to as listed medicines in Australia. Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.
Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the ARTG for listed medicines. At present, Schedule 4 of the Regulations does not include reference to sodium citrate or sodium acid citrate as active ingredients for oral medicines.
In order to facilitate the timely approval of new listable therapeutic goods, subsection 9A(5) of the Act allows the Minister for Health and Ageing to publish a listing notice that has the effect of permitting the use of particular therapeutic goods in listed medicines subject to any specified conditions.
Pursuant to subsection 9A(6) of the Act, if Schedule 4 of the Regulations is amended to include reference to a substance that has been the subject of a listing notice, that listing notice ceases to have effect.
Sodium citrate and sodium acid citrate are currently only permitted for use as excipients in Listed medicines. A number of other citrate salts are permitted as both active and excipient ingredients in Listed medicines. Citric acid anhydrous and citric acid monohydrate are also approved use as active ingredients in Listed medicines.
The available information on the safety and toxicity of citrate salts is limited, but indicates that citrate salts are substances of relatively low toxicity when administered via the oral route.
At its meeting in March 2009, the Complementary Medicines Evaluation Committee (CMEC) noted that sodium citrate and sodium acid citrate, previously permitted only for use as excipients in Listed medicines, would also be permitted for use as active ingredients in Listed medicines.
The Listing Notice provides for sodium citrate and sodium acid citrate to be used as active ingredients in oral Listed medicines.
CONSULTATION
Although the listing of sodium citrate and sodium acid citrate as active ingredients in Listed medicines for oral use is minor and machinery in nature, the CMEC was consulted during the approval process for this ingredient.
Overview
The Therapeutic Goods (Listing) Notice 2009 (No. 2) was enacted in 2009 by the Minister for Health and Ageing under section 9A(5) of the Therapeutic Goods Act 1989. This Notice was introduced to address the gap in the existing regulatory framework concerning the use of sodium citrate and sodium acid citrate as active ingredients in listed medicines for oral use. The Act itself was established to create a national system ensuring the quality, safety, efficacy and timely availability of therapeutic goods in Australia, with the Therapeutic Goods Administration (TGA) overseeing its implementation. The primary objective of this Notice is to allow the use of specified substances as active ingredients in listed medicines, thereby facilitating the timely approval of new therapeutic goods.
The Therapeutic Goods (Listing) Notice 2009 (No. 2) specifically permits sodium citrate and sodium acid citrate to be used as active ingredients in listed medicines intended for oral consumption. This decision was made after consultation with the Complementary Medicines Evaluation Committee (CMEC), which acknowledged the relatively low risk associated with the oral administration of citrate salts. The Notice streamlines the approval process for these substances, aligning with the broader policy objective of ensuring that therapeutic goods available in Australia meet necessary safety and efficacy standards.
Scope and Application
The Therapeutic Goods (Listing) Notice 2009 (No. 2) applies to the use of sodium citrate and sodium acid citrate as active ingredients in listed medicines for oral use in Australia. This notice is a mechanism under the Therapeutic Goods Act 1989, which mandates that therapeutic goods must be included in the Australian Register of Therapeutic Goods before they can be supplied, imported, manufactured, or exported within Australia. The Therapeutic Goods Administration (TGA) is responsible for overseeing the implementation of this Act. The notice was issued to allow the specified substances to be included as active ingredients in listed medicines, which are typically considered to be of low risk compared to prescription and over-the-counter medicines due to their limited therapeutic claims and approved low-risk ingredients. The use of sodium citrate and sodium acid citrate in listed medicines is subject to any specified conditions outlined in the notice. This legislative instrument applies nationally across Australia and is not restricted to any particular jurisdiction or industry, though it specifically targets the pharmaceutical industry and therapeutic goods manufacturers. The notice is subject to amendment or cessation if Schedule 4 of the Therapeutic Goods Regulations 1990 is subsequently updated to include these substances, thereby integrating them into the regulatory framework of listed medicines.
Key Provisions
The Therapeutic Goods (Listing) Notice 2009 (No. 2) (Listing Notice) under section 9A(5) of the Therapeutic Goods Act 1989 (the Act) permits the use of sodium citrate and sodium acid citrate as active ingredients in Listed medicines for oral use. This Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments. The Listing Notice allows these substances to be included in the Australian Register of Therapeutic Goods (ARTG) for Listed medicines, provided that any specified conditions are met. This means that Listed medicines containing these substances can now be legally supplied, imported, manufactured, or exported in Australia.
Entities and individuals involved in the manufacture, supply, or importation of therapeutic goods must comply with the provisions of the Listing Notice. This includes ensuring that any Listed medicines containing sodium citrate or sodium acid citrate as active ingredients are properly listed in the ARTG. Manufacturers and suppliers must adhere to the conditions specified in the Listing Notice to ensure that the therapeutic goods meet the required safety and quality standards. Failure to comply with these requirements may result in the therapeutic goods not being permitted in the ARTG, which could lead to legal consequences.
There are no specific offences or penalties outlined in the Listing Notice itself. However, breaches of the Therapeutic Goods Act 1989 or the Therapeutic Goods Regulations 1990 may result in civil or criminal penalties. For example, supplying therapeutic goods that do not comply with the requirements of the Act or Regulations may result in fines or imprisonment. The Therapeutic Goods Act 1989 provides for a range of penalties, including fines of up to $1,215,000 for corporations and up to $243,000 for individuals, as well as imprisonment terms that vary depending on the severity of the offence. The Therapeutic Goods Administration (TGA) is responsible for enforcing the Act and may take action against entities or individuals who do not comply with its provisions.